Kornimate/medical-research-clean huggingface dataset:
correlation of the arrhythmia mechanism and substrate to ablate persistent atrial fibrillation study

Conditions: Persistent Atrial Fibrillation

Summary: this is a pilot study to assess the usefulness of ecg mapping, and enhanced mri and pet scan imaging in identifying atrial fibrosis and arrhythmia circuits involved in persistent atrial fibrillation and in guiding an innovative af catheter ablation strategy. it is hypothesized that identifying these critical arrhythmia circuits and atrial fibrosis with enhanced imaging and performing an individualized innovative af catheter ablation will result in higher procedural success rates.

pulmonary vein isolation catheter ablation for the treatment of persistent af (peaf)or longstanding persistent af is associated with success rates of 40-50% at one year. experimental models have shown that af results in progressive structural changes due to electrical atrial remodeling, where af burden correlates with atrial fibrosis. the optimal ablation strategy for patients with peaf is not yet known. there is limited understanding of the critical mechanisms responsible for maintenance of af in these patients. in this study ecg body mapping (ecgi) will be used to look for distinct electrical rotors in the atria. delayed gadolinium enhanced magnetic resonance imaging (de-mri) will be used to assess the extent of left atrial fibrosis. in addition to pvi catheter ablation procedure, an ablation strategy guided by the results of the ecgi mapping and de-mri will be performed.a c-metahydroxyepherdrine (hed) pet scan will also be done pre-ablation to evaluate left atrial sympathetic denervation and any relationship to the initiation and/or maintenance of af. subjects will be seen at 3 and 6 months after ablation, with 12 lead ecg and 2-week loop monitoring done at each visit.

Eligibility criteria:
inclusion criteria: * age ≥18 years and ≤ 80 years; * symptomatic persistent af and clinically indicated for af catheter ablation * at least one episode of af lasting more than 7 days, documented on 12-lead ecg, holter monitor, 2-week loop monitor or trans-telephonic monitor (ttm) within 12 months of enrollment in the study * able to provide informed consent. exclusion criteria: * history of previous catheter or surgical ablation for af * presence of intracardiac thrombus * contraindication to systemic oral anticoagulation therapy * subjects with reversible causes of af * antero-posterior left atrial dimension \> 60 mm on echocardiography * severe valvular disease (mitral/aortic stenosis or regurgitation); * subjects that are pregnant or breastfeeding; * chronic kidney disease and creatinine clearance \<50ml/min. * contraindication to mri imaging (e.g. permanent pacemaker, metallic implants, etc)

Keywords: atrial fibrillation catheter ablation delayed gadolinium enhanced mri c-metahydroxyepherdrine (hed) pet scan ecgi mapping atrial fibrosis atrial sympathetic denervation
self-sampling for non-attenders to cervical cancer screening

Conditions: Cervical Cancer; Cervical Dysplasia; Human Papillomavirus Infection

Summary: the trial will evaluate whether self-sampling and human papillomavirus (hpv) testing may increase cervical cancer screening attendance among under-screened women in czech republic. different ways of offering self-sampling device will be evaluated.

despite the existence of an effective cervical cancer screening in the czech republic, cervical cancer is the cause of about 800 new cases and 400 deaths every year. one of the major problem of the czech cervical cancer screening is low participation. an effective strategy to increase cervical cancer screening attendance is one of the main challenges. the offering of self-sampling to the cervical cancer screening non-attenders could increase women's participation as was shown in several european countries. the trial should determine acceptability of the self-sampling followed by hpv dna test by czech women and therefore usability of the self-sampling device to increase cervical cancer screening attendance among under-screened women. three different approaches will be tested: women will receive a self-sampling device by mail (arm a); receive a self-sampling device by gynecologist (arm b); receive a self-sampling device by general practitioner (arm c). comparisons of the screening attendance among the arms will be made. to address also potential effects on inequities, the analyses will include comparisons by sociodemographic characteristics. women from the database of commercial vendor will be included to the arm a regardless of whether or not they participate in cervical cancer screening program. women who do not participate in cytology-based cervical cancer screening program for at least three years will be included through their gynecologist (arm b) or general practitioner (arm c) database. the second focus of the trial is the evaluation of high-risk human papillomavirus prevalence in screening population of czech women (attenders and non-attenders of cervical cancer screening) since there are no relevant data for the czech republic. study participants may volunteer for archiving of remaining biological materials for future studies.

Eligibility criteria:
inclusion criteria: * women with age 30-65 years; for arm a women \> 65 years are allowed * women live in the czech republic. * women who have not participate in cervical cancer screening program in the czech republic for at least 3 years (arm b and c). * women with completed informed consent. * women capable of self-sampling of cervicovaginal swab. exclusion criteria: * pregnant women. * women with no sexual intercourse experience. * women after hysterectomy including cervix.

Keywords: human papillomavirus hpv self-sampling cervicovaginal swab cervical cancer screening non-attendance
a comparison of efficacy and safety during endoscopic submucosal dissection between dexmedetomidine-remifentanil and propofol-remifentanil

Conditions: Early Gastric Cancer Patients Who Were Scheduled for Endoscopic Submucosal Dissection

Summary: adequate, safe sedation is essential for endoscopic submucosal dissection. dexmedetomidine is a potent and selective a2-adrenoceptor agonist used for sedative and analgesic effects, but it is limited to use alone. the investigators designed this study to compare the effect and safety of two sedatives, dexmedetomidine and propofol in endoscopic submucosal dissection (esd), when sufficient analgesia-remifentanil is administered all throughout the procedure.


Eligibility criteria:
inclusion criteria: * age ≥20 * american society of anaesthesiologists(asa) physical status classification i\~iii * early gastric cancer patients who were scheduled for endoscopic submucosal dissection exclusion criteria: * age \< 20 * american society of anaesthesiologists(asa) physical status classification iv * those with end-organ diseases (i.e. heart failure, respiratory failure, hepatic failure, renal failure) * known drug allergies or history of drug abuse * psychological disease

Keywords: endoscopic submucosal dissection propofol remifentanil dexmedetomidine efficacy safeness
effects of docosahexaenoic acid (dha) on children with nonalcoholic fatty liver disease (nafld)

Conditions: Fatty Liver; Liver Fibrosis; Obesity; Metabolic Syndrome; Nonalcoholic Fatty Liver Disease

Summary: the purpose of this interventional study is to evaluate the efficacy and tolerability of docosahexaenoic acid (dha) in children or adolescents with well-characterized and liver biopsy confirmed nonalcoholic fatty liver disease (nafld).

sixty children or adolescents (4-16 years) with liver biopsy proven nafld will be enrolled. they will be randomized to treatment with dha 250 mg/kg/d (n=20), dha 500 mg/kg/d (n=20), or an identical placebo (n=20) given orally for a period of 24 months. all patients will be included in a lifestyle intervention program consisting of a diet tailored on the individual requirements and physical exercise. patients will undergo a medical evaluation every three months during the 24-month study period. liver biopsy will be performed only at baseline and at the end of treatment. anthropometric analysis, laboratory tests, including liver enzymes and lipids will be repeated at 3-month intervals during the 24-month study duration. ultrasonography and fibroscan of the liver will be repeated at the end of the study period.

Eligibility criteria:
inclusion criteria: * persistently elevated serum aminotransferase levels * diffusely echogenic liver on imaging studies suggestive of fatty liver * biopsy consistent with the diagnosis of nafld exclusion criteria: * hepatic virus infections (hcv rna-pcr negative) * hepatitis a, b, c, d, e and g * cytomegalovirus and epstein-barr virus * alcohol consumption * history of parenteral nutrition * use of drugs known to induce steatosis or to affect body weight and carbohydrate metabolism * autoimmune liver disease, metabolic liver disease, wilson's disease, and a-1-antitrypsin-associated liver disease were ruled out using standard clinical, laboratory and histological criteria

Keywords: nafld nash fibrosis
staphvax in cardiovascular surgery patients

Conditions: Staphylococcal Infections; Cardiovascular Diseases; Cardiovascular Surgical Procedures

Summary: s. aureus is the most common pathogen encountered in infection associated with cardiovascular surgery. staphvax® is a bivalent s. aureus types 5 and 8 vaccine which contains the purified capsular polysaccharides (cps) that have been implicated as a major factor in the invasiveness of s. aureus. immunoprophylaxis by vaccinating against s. aureus prior to surgery could provide sufficient antibody concentrations during surgery and during the wound healing period so as to decrease the risk of s. aureus infection. this study aims to demonstrate the immunogenicity and safety of a single dose of staphvax in patients who are candidates for cardiovascular surgery.


Eligibility criteria:
inclusion criteria: * candidate for cardiovascular surgery * expected to comply with protocol * negative pregnancy test where appropriate * written informed consent exclusion criteria: * known s. aureus infection in past 3 months * known infection in the past 2 weeks * known hiv infection * pregnancy or breast-feeding * immunomodulatory drugs * malignancy or treatment for malignancy within the past six months, other than basal cell, localized squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or early stage prostate cancer * investigational drugs, vaccines or products in the past 30 days * hypersensitivity to components of staphvax
effects of muscle flossing on quadriceps muscle potentiation

Conditions: Ischemia; Placebo - Control

Summary: tissue flossing involves wrapping a thick rubber band around a joint or muscle, which can partially occlude blood flow. in practice, it is often used while concomitantly performing a range of motion exercises (rom) for 1 to 3 minutes in duration. the mechanisms involved in tissue flossing with a floss band may be similar to those involved in ischemic preconditioning. previous results would support the use of tissue flossing on rom, while there are no clear conclusions on post-activation effects on sports-related performance and muscle contractile properties. this may be attributed to the different methodologies used in the studies. therefore, the time course associated with tissue flossing benefits remains to be investigated.

nowadays, various methods are used for acute performance enhancement. the most recent of these is tissue flossing, which is becoming increasingly popular for both performance enhancement and rehabilitation. however, the effects of flossing on athletic performance have not been clearly demonstrated, which could be due to differences in the methodology used. in particular, the rest periods between the end of the preconditioning activity and the performance of the criterion task or assessment tools varied considerably in the published literature. therefore, the present study aimed to investigate the effects of applying tissue flossing to the thigh on bilateral countermovement jump performance and contractile properties of vastus lateralis (vl) muscle. nineteen recreational athletes (11 males; aged 23.1 ± 2.7 years) were randomly assigned to days of flossing application (3 sets for 2 min of flossing with 2 min rest between sets) with preset experimental pressure (exp = 95 ± 17.4 mmhg) or control condition (con = 18.9 ± 3.5 mmhg). the first part of the measurements was performed before and after warm-up consisting of 5 min of cycling followed by dynamic stretching and specific jumping exercises, while the second part consisted of six measurement points after flossing application (0.5, 3, 6, 9, 12, 15 min).

Eligibility criteria:
inclusion criteria: * healthy and physically active individuals * without a history of lower limb injuries and/or surgeries at least 1 year prior to investigation. exclusion criteria: * neuromuscular and metabolic disorders; * the presence of acute and/or chronic pain * alcohol and drug consumption etc.

Keywords: tissue flossing
china post-approval commitment (pac) study of avalglucosidase alfa in participants with iopd

Conditions: Glycogen Storage Disease Type II; Pompe's Disease

Summary: this is a single group, 52-week treatment, phase 4, open-label, single-arm study to assess the safety and efficacy of avalglucosidase alfa iv infusion in male and female chinese participants with iopd who are treatment-naïve or were previously treated with ert. study details include: * the study duration: total study duration is approximately 64 weeks. * screening period of up to 8 weeks * treatment period of 52 weeks * follow-up period of 4 weeks. * the number of visits will be 30, including 29 site visits and 1 phone call follow-up visit.


Eligibility criteria:
inclusion criteria: * participant must be \<18 years of age, at the time of signing the informed consent. * participants have documented onset of pompe disease symptoms before 12 months of age (corrected for gestation if born before 40 weeks); and diagnosis of iopd is confirmed by gaa enzyme deficiency from any tissue source and gaa gene pathogenic mutations. * participants must have documented cardiomyopathy at the time of diagnosis. * contraceptive use should be consistent with local regulations participant's parent/legally authorized representative (lar) must be capable of giving signed informed consent. exclusion criteria: participants are excluded from the study if any of the following criteria apply: * participants with major congenital abnormality that, in the opinion of the investigator, would preclude participation in the study or potentially decrease survival. * participants with clinically significant organic disease (with the exception of symptoms relating to pompe disease). * participants who have received an ert other than alglucosidase alfa or avalglucosidase alfa, or any other treatment for pompe disease, including gene therapy prior to the enrollment. * participants who have received alglucosidase alfa or avalglucosidase alfa less than 1 week prior to the first dose of avalglucosidase alfa given as imp participants who are anticipated to take prohibited therapy (ie, any other treatment for pompe disease) during this study. * participants who have taken other investigational drugs (not pompe disease specific) within 30 days or 5 elimination half-lives in blood of that drug before enrollment, whichever is longer, or are anticipated to take any other concurrent investigational treatments. * participants not suitable for participation, whatever the reason, as judged by the investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures.
effects of adalat la and coracten on drug levels, blood pressure, and heart rate in fed patients with hypertension

Conditions: Hypertension

Summary: this study compares the effect of adalat la to coracten on drug levels as well as changes in blood pressure and heart rate in fed hypertensive subjects. subjects are dosed with either adalat or coracten for first 2 weeks, followed by the other drug for 2 weeks, and then switched back to the original drug for one day. blood samples, blood pressure, and heart rate are taken before and after each treatment period.


Eligibility criteria:
inclusion criteria:- mild to moderate hypertension (sitting dbp \> 95 - \ 140 - \ 1.5 mg/dl), which could alter the absorption, metabolism or excretion of the study drugs.- subjects with type i diabetes. - subjects taking drugs which may interfere with the metabolism of nifedipine (cimetidine, ranitidine, quinidine, digoxin, rifampicin, diltiazem, cisapride, quinupristin/dalfopristin, cyclosporin, phenytoin or other antiepileptic drugs,).- subjects suffering from secondary or malignant hypertension.- subjects with any known contraindication (e.g. hypersensitivity) to nifedipine or other calcium channel blockers of the dihydropyridine class.- subjects with previously known clinically significant abnormalities of laboratory tests that might suggest further investigation.- subjects with a resting heart rate \ 100 bpm.- subjects with a history of drug and/or alcohol abuse.- subjects unwilling to comply with the protocol.- subjects who have participated in another clinical trial within the last month.- subjects with neurologic or psychiatric illness requiring medication (e.g. tricyclic antidepressants, mao inhibitors).- subjects with clinical evidence of ongoing or recent (within the last year) stroke or transient ischemic attacks.- subjects with pre-existing severe gastrointestinal or oesophageal constriction or narrowing.
effects of pioglitazone combined with metformin on gonadal and metabolic profiles in chinese nonobese pcos patients.

Conditions: Polycystic Ovary Syndrome

Summary: to study the effects of pioglitazone combined with metformin and metformin on gonadal and metabolic profiles in pcos patients with bmi \< 24 in china. 60 cases of nonobese pcos patients were collected from shengjing hospital. the intervention period was 3 months after intervention with met or met + ph. to evaluate the improvement of met or met + ph in the treatment of hyperandremia, glucose metabolism, bmi, waist circumference, menstruation, hairiness and acne in pcos patients.


Eligibility criteria:
inclusion criteria: 1. females 18 years to 40 years of age diagnosed as pcos by the 2003 rotterdam criteria 2. bmi\<24 kg/m2 3. no pregnant plan in recent 6 months 4. written consent for participation in the study exclusion criteria: 1. type 1 or type 2 diabetes mellitus 2. subjects have other endocrine diseases, such as adrenal hyperplasias or tumor, androgen-secreting tumors, cushing's syndrome, thyroid diseases, and hyperprolactinemia 3. diagnosed with or have a family history of medullary thyroid carcinoma (mtc) or multiple endocrine neoplasia syndrome type 2 (men 2) 4. serious systemic disease or malignant tumor 5. history of pancreatitis (chronic, acute or recurrent) 6. body weight change ≥10% at 3 months before treatment 7. used oral contraceptives or sex hormone drugs in the past 1 month 8. used oral glucocorticoids in the past 1 month 9. substance (alcohol or drug) abuse or dependence within 3 months 10. heavy smokers (smokers who smoke 20 or more cigarettes a day) or heavy drinkers (\>10g/d) 11. subjects have a severe systemic disease, such as cardiovascular system, renal impairment (egfr\<60ml/min/1.73m2) 12. increase of transaminases up to \< 2.5 times of upper limit of normal value 13. have a history of thromboembolic disease or thrombotic tendency 14. subjects in pregnant or lactating or within 1 year after delivery 15. subjects have an allergic history to the drugs used in the study 16. subjects have participated in other clinical researches of medicine within 1 month prior to randomization 17. use of metformin, pioglitazone, or pioglitazone combined with metformin within 30 days before screening
identifying immune-related biomarkers to predict the efficacy of cancer immunotherapy

Conditions: Lung Cancer Metastatic; Locally Advanced Malignant Neoplasm; Non Hodgkin Lymphoma; Urologic Neoplasms

Summary: the development of immune checkpoint blockade (icb) is a revolution in medical oncology as icb have changed the standard treatments of several metastatic tumor types. however, the response rate to icb is low, and the biological bases for this response heterogeneity are poorly understood. in the frame of immunosup study, we will collect blood (at baseline, post infusion of icb n°2/4/8 and at progression) and tumor samples (optional: at baseline and progression) from patients with locally advanced or metastatic cancer, treated with icb, in order to determine if the dynamics of immunosuppressive actors (mdsc, treg, immunosuppressive cytokines) predicts response to these immunotherapies.


Eligibility criteria:
inclusion criteria: * age \> 18 years * diagnosis of locally advanced or metastatic solid tumor or lymphoma treated with immune check blockade * signed informed consent * affiliated to(or beneficiary of) the french social security exclusion criteria: * pregnant or breastfeeding woman or woman who does not apply effective contraception * emergency * vulnerable person or unable to provide informed consent * emergency * person unable to comply with required study follow up * contraindication to the study procedure

Keywords: immune check point blockade biomarkers immunomonitoring
gcf levels of il-1beta, mip-1 alfa and g-csf in gingivitis and stage i-ii-iii-iv periodontitis patients

Conditions: Periodontitis

Summary: periodontal diseases are chronic diseases that occur as a result of a violation of the balance between microbial dental plaque and the host response. gingivitis is a disease characterized by inflammation of the gums that occurs in one or more areas without loss of attachments.1 in periodontitis, an inflammatory event that begins in the gum along with gingivitis spreads to the periodontal ligament, alveolar bone and soft tissues that support the tooth, causing the destruction of these structures.2 cytokines are low molecular weight proteins that participate in the initial and active stages of inflammation and immunity. in periodontal disease pathogenesis, cytokine response has been reported to play a very critical role in determining disease progression.3 il-1beta, mip-1alfa and g-csf are key cytokines in chronic inflammatory diseases and have the potential to initiate bone loss and tissue destruction seen in periodontal disease.4the purpose of this study; it is to determine the degree of inflammation and periodontal destruction by determining the levels of il-1beta, mip-1alfa, g-csf cytokines in the gum groove fluid of periodontal healthy and diseased individuals.

plaque index (pi), gingival index (gi), presence of bleeding on probing (bop), pocket depth (pd) and clinical attachment level (cal) were used after clinical evaluation, individuals were divided into 6 groups healthy control groups, gingivitis groups, stage i groups, stage ii groups, stage iii groups and stage iv groups gcf samples were collected after clinical periodontal measurement. gcf was obtained using strips of filter paper kolmogorov-smirnov and shapiro wilk's tests used

Eligibility criteria:
inclusion criteria: * clinical diagnosis of periodontal diseases * individuals must have 16 permanent teeth in their mouth exclusion criteria: * diabetes * i̇mmunological diseases

Keywords: periodontal disease periodontitis cytokines